Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572475
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-15
Brief Title:
USPIO Enhanced MR Imaging in CNS Tumours UMIC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
USPIO Enhanced MR Imaging in CNS Tumours UMIC A Pilot Study of Ferumoxytol Feraheme as an Imaging Biomarker of Tumour Associated Macrophage TAM Infiltration in Vestibular Schwannoma VS and Transforming Low Grade Glioma LGG
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UMIC
Brief Summary:
The immune response or inflammation is known to be a key driver of progression and growth in many solid tumours Inflammatory cells called macrophages are present in high numbers in many brain tumours and these tumour associated macrophages or TAM are thought to have prognosis and treatment implications in these tumours A key question however is how this inflammation or TAM abundance can be detected measured and monitored in the clinic A clinically applicable imaging test that can directly and accurately measure tumour macrophage content would be of considerable value and one technique that may provide this is USPIO enhanced magnetic resonance imaging MRI Following intravenous injection USPIO or ultrasmall superparamagnetic iron oxide nanoparticles circulate in the bloodstream before being taken up by inflammatory cellsmacrophages in tumour tissue wherein they can be detected by MRI This pilot study is to evaluate if a commercially available USPIO preparation called ferumoxytol Feraheme can accurately quantify macrophage abundance in brain tumours with an exploratory focus on vestibular schwannoma VS and suspected transforming low-grade glioma LGG Patients with both non-growing static and growing VS and patients with suspected transforming LGG will undergo dedicated MRI sequences before immediately after 2 hours and at both 24 and 48hrs after ferumoxytol administration In patients undergoing surgery acquired imaging will be compared with resected tumour tissue so that markers of inflammation can be compared with USPIO uptake Through advanced laboratory methods this study will seek to establish within resected VS and LGG specimens the cellular destinations of USPIO uptake the nature of the inflammatory andor tumour cells containing the USPIO and the relationship between USPIO uptake and tumour blood vessel permeability or leakiness
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None